Tag: OPDP enforcement

OPDP enforcement

Regulatory/FDA

OPDP Issues Enforcement Letter for Investigational Drug Promotion

OPDP Issues Enforcement Letter for Investigational Drug Promotion

April 30, 2019 – In its first enforcement letter of 2019, the FDA’s Office of Prescription Drug Promotion (OPDP) asserts that an article posted on a sponsor’s website misbrands the investigational drug “Sodium Acetate C-11” (11-C Acetate) because it suggests in a promotional context that the drug is safe and effective for the purpose for […]

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Regulatory/FDA

OPDP Cites Lack of Risk Information in Second Warning Letter of 2018

OPDP Cites Lack of Risk Information in Second Warning Letter of 2018

Nov. 2, 2018 – Providing information about a drug product’s benefits without including any risks is an issue that the FDA’s Office of Prescription Drug Promotion (OPDP) does not take lightly, as evidenced by an Oct. 22 Warning Letter from OPDP to Vanda Pharmaceuticals Inc. This Warning Letter is the second Warning Letter issued in […]

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Off-label Promotion

Bad Ad Program Yields Two OPDP Enforcement Letters on Risk, Safety Information

Bad Ad Program Yields Two OPDP Enforcement Letters on Risk, Safety Information

Oct. 19, 2018 — The FDA’s Office of Prescription Drug Promotion (OPDP) issued two enforcement actions in less than a week that focused on alleged safety and risk information infractions for products with Boxed Warnings; both matters were brought to the agency’s attention through OPDP’s Bad Ad program. “These letters are significant not because they […]

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